The Impact of Continuous Glucose Monitoring on Maternal and Infant's Outcomes in Gestational Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNational Taiwan University Hospital
About this trial
This study will discuss the impact of continuous glucose monitoring on maternal and infant's outcomes in gestational diabetes mellitus, and test the moderating effect of socioeconomic and cultural factors (dietary habits, socioeconomic status and income).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or above
Pregnant women diagnosed with gestational diabetes mellitus
Those who are willing to participate in this study
Disqualifiers
Those who have been diagnosed with diabetes mellitus "before pregnancy"
Those whose skin is likely allergic to some materials such as tapes (signs and symptoms such as redness, swelling, itching, painful, presenting blisters or rashes caused by wearing breathable tapes, patches, etc.)
Those who is with abnormal coagulation function
Trial design
Design model
Parallel
Treatments tested in this trial
Continuous glucose monitor
DeviceParticipants will receive a set of continuous glucose monitor (CGM) at "24-32 weeks of pregnancy (first set)" and "33 weeks of pregnancy to before delivery (second set)," respectively. CGM wearing instruction will be provided before the first wearing at "24-32 weeks of pregnancy". After completing the first wearing (approximately 14 days after starting to wear), the investigators will provide a glucose monitor report. The second CGM was worn from the 33rd week of pregnancy to before delivery, and another glucose monitor report was given approximately 14 days after starting to wear.
Perinatal nursing care for gestational diabetes
BehavioralIndividual nursing care and consultation for pregnant women with gestational diabetes mellitus, including glucose monitor suggestions, dietary suggestions, emotional support, breastfeeding support.
Blood glucose meters (BGM)
Other interventionParticipants are required to use blood glucose meters (BGM) at "24-32 weeks of pregnancy" and "33 weeks to before delivery". After 14 days of glucose monitoring at "24-32 weeks of pregnancy", a glucose monitor report will be given to the participants. After the 14 days of glucose monitoring at "33 weeks to before delivery ", another glucose monitor report will be given to the participants.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Controlled group-Blood glucose meters (BGM) groupOther 1 intervention
Group B: Experimental group1-Continuous glucose monitoring (CGM) groupExperimental treatment 1 intervention
Group C: Experimental group2-Continuous glucose monitoring (CGM) with nursing care groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Maternal Oral glucose tolerance test
Oral glucose tolerance test (OGTT) including fasting, 1-hour, and 2-hour glucose levels.
Time frame
24-32 weeks of pregnancy, 4-12 weeks postpartum2
Maternal glycated albumin
glycated albumin
Time frame
24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum3
Maternal albumin
albumin
Time frame
24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum4
Maternal fasting plasma glucose
fasting plasma glucose
Time frame
24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartumSecondary outcomes
1
Gestational weight gain
Gestational weight gain will be based on pre-pregnancy Body Mass Index (BMI) and classified according to the Institute of Medicine (IOM) recommendations.
Time frame
24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery2
Depression
Edinburgh Postnatal Depression Scale (EPDS) The EPDS is a 10-item questionnaire. Each item scores from 0-3. The total score is found by adding together the scores for each of the 10 items. The minimum is 0 and the maximum is 30. Scoring above 12 or 13 are likely to be suffering from depression.
Time frame
24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum3
Infant growth curve
infant growth curve
Time frame
4-12 weeks postpartum4
Maternal average fasting plasma glucose
average fasting plasma glucose
Time frame
24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartumSponsors and contacts
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Source ClinicalTrials.gov